Trial · NCT00117572
Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)
NCT00117572, Phase 3, Completed, University of Chicago; results first posted 2018-04-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE). Trials, record NCT00117572. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00117572
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)
- NCT number
- NCT00117572
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 285 participants, actual
- Lead sponsor
- University of Chicago
- Conditions
- Cancer of the Pharynx, Cancer of the Larynx, Cancer of the Nasal Cavity, Paranasal Sinus Neoplasms, Cancer of the Oral Cavity
- Interventions
- docetaxel, cisplatin, hydroxyurea, fluorouracil, chemotherapy, radiotherapy
- First posted
- 2005-07-07
- Last updated
- 2018-04-09
- Results first posted
- 2018-04-09
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival: Time From Randomization to Death From Any Cause | Up to 6 years | Survival rates over 6 years. |
| Secondary | Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause | Up to 6 years | DFFS rates over 6 years. DFFS is time from randomization to distant recurrence or death from any cause |
| Secondary | Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause | Up to 6 years | Recurrence-free survival rates over 6 years. Recurrence-free survival is time from randomization to local, regional, or distant recurrence or death from any cause |
| Secondary | Failure Pattern (Local/Regional Recurrence) | Up to 6 years | Percentage of patients with local/regional recurrence |
| Secondary | Failure Pattern (Distant Recurrence) | Up to 6 years | Percentage of patients with distant recurrence |
| Secondary | Quality of Life (FACT H&N) | Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm. | FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function) |
| Secondary | Quality of Life (Normalcy of Diet) | Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm. | Performance Status Score (0-100 point scale with negative numbers indicating worsening of function) |
| Secondary | Quality of Life (Speech) | Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm. | Performance Status Score (0-100 point scale with negative numbers indicating worsening of function) |
| Secondary | Quality of Life (McMaster) | Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm. | McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function) |
| Secondary | Quality of Life (FACT H&N) | Change from baseline to 1 year (1 year-pre) | FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival: Time From Randomization to Death From Any Cause | Up to 6 years | percentage of participants | NUMBER | |
| SECONDARY | Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause | Up to 6 years | percentage of participants | NUMBER | |
| SECONDARY | Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause | Up to 6 years | percentage of participants | NUMBER | |
| SECONDARY | Failure Pattern (Local/Regional Recurrence) | Up to 6 years | percentage of participants | NUMBER | |
| SECONDARY | Failure Pattern (Distant Recurrence) | Up to 6 years | percentage of participants | NUMBER | |
| SECONDARY | Quality of Life (FACT H&N) | Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm. | Survivors who completed the questionnaire. (Patients with missing data excluded.) | units on a scale | MEAN |
| SECONDARY | Quality of Life (Normalcy of Diet) | Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm. | Survivors who completed the questionnaire. (Patients with missing data excluded.) | units on a scale | MEAN |
| SECONDARY | Quality of Life (Speech) | Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm. | Survivors who completed the questionnaire. (Patients with missing data excluded.) | units on a scale | MEAN |
| SECONDARY | Quality of Life (McMaster) | Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm. | Survivors who completed the questionnaire. (Patients with missing data excluded.) | units on a scale | MEAN |
| SECONDARY | Quality of Life (FACT H&N) | Change from baseline to 1 year (1 year-pre) | Survivors who completed the questionnaire. (Patients with missing data excluded.) | units on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival: Time From Randomization to Death From Any Cause | Induction Plus Chemoradiotherapy | 74.9 | 95% Confidence Interval 67.4 to 82.4 | percentage of participants | |
| Overall Survival: Time From Randomization to Death From Any Cause | Chemoradiotherapy | 72.8 | 95% Confidence Interval 65.1 to 80.6 | percentage of participants | |
| Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause | Induction Plus Chemoradiotherapy | 69.3 | 95% Confidence Interval 61.1 to 77.5 | percentage of participants | |
| Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause | Chemoradiotherapy | 63.8 | 95% Confidence Interval 55.4 to 72.2 | percentage of participants | |
| Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause | Induction Plus Chemoradiotherapy | 68.6 | 95% Confidence Interval 60.6 to 76.7 | percentage of participants | |
| Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause | Chemoradiotherapy | 58.6 | 95% Confidence Interval 49.9 to 67.2 | percentage of participants | |
| Failure Pattern (Local/Regional Recurrence) | Induction Plus Chemoradiotherapy | 10.1 | 95% Confidence Interval 5.7 to 16.4 | percentage of participants | |
| Failure Pattern (Local/Regional Recurrence) | Chemoradiotherapy | 12.6 | 95% Confidence Interval 7.5 to 19.4 | percentage of participants | |
| Failure Pattern (Distant Recurrence) | Induction Plus Chemoradiotherapy | 13.8 | 95% Confidence Interval 8.5 to 20.7 | percentage of participants | |
| Failure Pattern (Distant Recurrence) | Chemoradiotherapy | 21.5 | 95% Confidence Interval 14.9 to 29.4 | percentage of participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Induction Plus Chemoradiotherapy | 144 | |
| Overall Study | STARTED | Chemoradiotherapy | 141 | |
| Overall Study | COMPLETED | Induction Plus Chemoradiotherapy | 138 | |
| Overall Study | COMPLETED | Chemoradiotherapy | 135 | |
| Overall Study | NOT COMPLETED | Induction Plus Chemoradiotherapy | 6 | |
| Overall Study | NOT COMPLETED | Chemoradiotherapy | 6 |
Source ClinicalTrials.gov
Adverse events286
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Induction Plus Chemoradiotherapy | 118 | 138 | |
| other | Fatigue | General disorders | Chemoradiotherapy | 94 | 135 | |
| other | Fever | General disorders | Induction Plus Chemoradiotherapy | 31 | 138 | |
| other | Fever | General disorders | Chemoradiotherapy | 30 | 135 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Induction Plus Chemoradiotherapy | 63 | 138 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Chemoradiotherapy | 34 | 135 | |
| other | Dermatitis radiation | Injury, poisoning and procedural complications | Induction Plus Chemoradiotherapy | 101 | 138 | |
| other | Dermatitis radiation | Injury, poisoning and procedural complications | Chemoradiotherapy | 111 | 135 | |
| other | Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | Induction Plus Chemoradiotherapy | 25 | 138 | |
| other | Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | Chemoradiotherapy | 14 | 135 |
1 to 10 of 286Source ClinicalTrials.gov
See all 286 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Induction Plus Chemoradiotherapy | 39 | 138 |
| Total, all-cause mortality | Chemoradiotherapy | 42 | 135 |
| Total, other adverse events | Induction Plus Chemoradiotherapy | 132 | 138 |
| Total, other adverse events | Chemoradiotherapy | 129 | 135 |
| Total, serious adverse events | Induction Plus Chemoradiotherapy | 65 | 138 |
| Total, serious adverse events | Chemoradiotherapy | 38 | 135 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Induction Plus Chemoradiotherapy vs Chemoradiotherapy: deaths from any cause | Trial comparisons |
| Induction Plus Chemoradiotherapy vs Chemoradiotherapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00117572
GET https://conductscience.org/api/trials/v1/NCT00117572/results?page=2